Apparatus and method for delivery and/or removal of occlusions in the body

Abstract

Delivery systems for providing occlusive hydrogels in a tube lumen or void space within the body including but not limited to a reproductive tract such as the vas deferens or fallopian tubes for contraception are described. The delivery systems contain mechanisms that confirm proper placement of the system in the bodily lumen prior to the delivery of the occlusive material. The systems also can contain a confirmatory mechanism that demonstrates the blockage or occlusion in the bodily lumen has been achieved following the deposition of the occlusive material. Another aspect of this application is to provide a removal system that delivers dissolving material, agitates, aspirates, and confirms the patency of the bodily lumen following the removal of the occlusive material if so desired by the patient for the return to fertility.

We claim: 
     
       1. A method of confirming intraluminal access of a lumen in a body comprising:
 inserting a sheath into the body; 
 advancing a probe relative to the sheath by an advancing distance into the lumen; 
 confirming the sheath has access to the lumen if the advancing distance is greater than or equal to a threshold distance; 
 agitating a first material in the lumen with the probe; 
 irrigating a second material into the lumen; and 
 aspirating the first material from the lumen. 
 
     
     
       2. The method of  claim 1 , wherein advancing the probe relative to the sheath by the advancing distance into the lumen comprises advancing the probe out of the sheath by the advancing distance. 
     
     
       3. The method of  claim 1 , wherein confirming the sheath has access to the lumen if the advancing distance is greater than or equal to the threshold distance comprises confirming the sheath is in the lumen if the advancing distance is greater than or equal to the threshold distance. 
     
     
       4. The method of  claim 1 , wherein inserting the sheath into the body comprises inserting a port into the body, and wherein confirming the sheath has access to the lumen if the advancing distance is greater than or equal to the threshold distance comprises confirming the port has access to the lumen if the advancing distance is greater than or equal to the threshold distance. 
     
     
       5. The method of  claim 1 , further comprising delivering the first material into the lumen after confirming the sheath has access to the lumen, wherein the first material comprises a hydrogel or is configured to alter a physical property and/or a chemical property of an implant. 
     
     
       6. The method of  claim 1 , further comprising removing the first material from the lumen after confirming the sheath has access to the lumen, wherein the first material comprises a hydrogel, and wherein the second material is configured to alter a physical property and/or a chemical property of the hydrogel. 
     
     
       7. The method of  claim 1 , wherein the lumen comprises a lumen of a reproductive tract. 
     
     
       8. The method of  claim 1 , wherein the first material comprises a hydrogel. 
     
     
       9. The method of  claim 1 , wherein the second material is configured to physically and/or chemically alter the first material. 
     
     
       10. A method of confirming intraluminal access of a body lumen and removing a first material from the body lumen, the method comprising:
 inserting a sheath into a body having the body lumen; 
 advancing a probe relative to the sheath by an advancing distance into the body lumen; 
 confirming the sheath has access to the body lumen if the advancing distance is greater than or equal to a threshold distance; 
 agitating the first material in the body lumen with the probe; 
 irrigating a second material into the body lumen; and 
 aspirating the first material and the second material from the body lumen. 
 
     
     
       11. The method of  claim 10 , wherein agitating the first material in the body lumen with the probe comprises moving the probe relative to the sheath in the body lumen. 
     
     
       12. The method of  claim 11 , wherein moving the probe relative to the sheath in the body lumen comprises translating, rotating, and/or vibrating the probe in the body lumen. 
     
     
       13. The method of  claim 10 , wherein agitating the first material in the body lumen with the probe comprises mechanically breaking down the first material with the probe. 
     
     
       14. The method of  claim 10 , wherein the lumen comprises a lumen of a reproductive tract. 
     
     
       15. The method of  claim 10 , further comprising agitating the second material in the body lumen with the probe. 
     
     
       16. A device comprising:
 a sheath; and 
 a probe, 
 wherein the probe is advanceable from a retracted configuration to an advanced configuration relative to the sheath, 
 wherein when the probe is in the retracted configuration, a first distance is between the probe and the sheath, 
 wherein when the probe is in the advanced configuration, a second distance greater than the first distance is between the probe and the sheath, 
 wherein the first distance is less than a threshold distance, and 
 wherein when the second distance is greater than or equal to the threshold distance, the advanced configuration of the probe comprises an indicator to a user that the device has access to a target site. 
 
     
     
       17. The device of  claim 16 , wherein when the second distance is greater than or equal to the threshold distance, the advanced configuration of the probe comprises an indicator to a user that the sheath and/or a port has access to the target site. 
     
     
       18. The device of  claim 16 , wherein the sheath comprises a sheath lumen, and wherein more of the probe is distal the sheath lumen when the probe is in the advanced configuration than when the probe is in the retracted configuration. 
     
     
       19. The device of  claim 16 , further comprising a material and a material reservoir, wherein a flow path extends between the material reservoir and a distal end of the sheath, wherein the device has a first configuration, a second configuration, and a third configuration, wherein before the second distance becomes greater than or equal to the threshold distance, the device has the first configuration, wherein when the second distance becomes greater than or equal to the threshold distance, the device has the second configuration or the device is changeable from the first configuration to the second configuration, wherein after the second distance becomes greater than or equal to the threshold distance, the device has the third configuration, wherein when the device is in the first configuration, the material is in the material reservoir and the flow path is open or closed, wherein when the device is in the second configuration, the material is between the material reservoir and a distal terminal end of the sheath and the flow path is open or closed, and wherein when the device is in the third configuration, the material is distal a distal terminal end of the sheath and the flow path is open or closed. 
     
     
       20. The device of  claim 16 , further comprising an irrigator and/or an aspirator, wherein a distal end of the sheath comprises a port, wherein when the irrigator is irrigating, the port is in fluid communication with the irrigator, and wherein when the aspirator is aspirating, the port is in fluid communication with the aspirator.